Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576089
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Optimizing Recruitment to Drive Equitable Research Opportunity in Stroke Rehabilitation Trials in Canada
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Recruitment to Drive Equitable Research Opportunity in Stroke Rehabilitation in Canada - The ORDER Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORDER-P
Brief Summary:
Stroke is a major health issue in Canada Stroke affects over 400000 Canadians and this number is expected to nearly double by 2038 Research studies in stroke recovery can help us better understand effective rehabilitation treatments and help reduce the burden of stroke Some groups of people however are commonly not included in stroke studies For example it is more common for men to take part in research than women and people with aphasia a language impairment commonly seen after stroke are often excluded from studies Also deciding whether to even take part in a research study can be difficult and overwhelming especially in the early days after stroke leaving many people to decline to participate Research has shown that women experience different barriers to participating in stroke research than men This means that research findings and the decisions made during stroke care based on these findings may not reflect the true stroke population Better ways to help support groups like women and people with aphasia to participate in stroke research are needed so that study findings will better represent people living with stroke
Detailed Description:
Clinical trials in stroke recovery are essential for establishing effective treatments yet important groups such as women and people with aphasia have been consistently under-represented in stroke trials This limits the generalizability of trial findings and impacts clinical care Relevant to stroke is the critical time window for neuroplastic change that makes timely enrolment into stroke recovery trials of particular importance There is a need to develop strategies to efficiently and effectively promote participation into stroke recovery trials
The Optimizing Recruitment to Drive Equitable Research opportunity in stroke rehabilitation trials in Canada ORDER is a pilot study within a trial to look at a women-centred aphasia-friendly recruitment method for a research trial examining whether a medication Maraviroc when combined with rehabilitation can help with stroke recovery host trial
The objectives of this pilot study are to
1 Examine the feasibility of a women-centred aphasia-friendly video and leaflet ORDER to supplement traditional detailed participant information letters support recruitment and drive enrollment in a stroke recovery randomized trial
2 Understand the barriers and facilitators associated with enrolling in the host trial and stroke recovery trials more broadly
3 Determine preliminary estimates of effect of ORDER compared to traditional recruitment and enrollment processes
The study will take place at the 10 sites across 6 provinces The host trial is comparing Maraviroc vs placebo combined with 8 weeks of rehabilitation to improve motor and sensory function
Potential participants will be identified and approached 5 days to 8 weeks after stroke and randomized to 1 Supplementing traditional recruitment methods detailed participant information letter and consent form with women-centred aphasia-friendly recruitment video and leaflet ORDER or 2 Traditional participant information letter and consent form only TRAD For the ORDER arm the video and leaflet will be saved to a tablet and reviewed together with the Coordinator and potential participant The Coordinator will engage in discussion about the host trial prompting questions will be provided and will offer to leave the tablet with the person along with printed copies of the leaflet and participant information letter They will be encouraged to share these materials with their family members or friends who may assist with decision making For TRAD the Coordinator will review the information letter and consent form offer to leave these with the person to view again and encourage them to share these materials with their family members or friends who may assist with decision making For both arms the Coordinator will return in the following days to address any further questions and determine the decision whether to enroll in the trial
Objective 1 Feasibility will be determined as enrollment consentedapproached women consentedtotal consented and efficiency days to decision interactions between Site Coordinator and potential participants with a priori criteria for success for each indicator
For Objective 2 Barriers and facilitators individuals will be invited to complete a survey or participate in key-informant semi-structured interviews 15 enrolled 15 declined 10 Site Coordinators to share their perceptions of the enrollment and consent process reasons for declining to participate and recruitment reach and characteristics of individuals enrolled through ORDER and TRAD Purposive sampling will be used to obtain diversity across sex males females gender men women transgender non-binary and racial background and will train peer researchers with lived experience to conduct the interviews The interview guide will be co-developed with our patient partners and the research team Deductive content analysis of interview transcripts will be conducted and mapped to the Theoretical Domains Framework
For Objective 3 Preliminary estimates of effect enrollment and efficiency will be compared between ORDER and TRAD and Cohens d and f will be calculated for unadjusted and adjusted analyses to help inform future large-scaled trials
The Optimizing Recruitment to Drive Equitable Research opportunity in stroke rehabilitation trials in Canada ORDER is a pilot study within a trial to look at a women-centred aphasia-friendly recruitment method for a research trial examining whether a medication Maraviroc when combined with rehabilitation can help with stroke recovery host trial
The objectives of this pilot study are to
1 Examine the feasibility of a women-centred aphasia-friendly video and leaflet ORDER to supplement traditional detailed participant information letters support recruitment and drive enrollment in a stroke recovery randomized trial
2 Understand the barriers and facilitators associated with enrolling in the host trial and stroke recovery trials more broadly
3 Determine preliminary estimates of effect of ORDER compared to traditional recruitment and enrollment processes
The study will take place at the 10 sites across 6 provinces The host trial is comparing Maraviroc vs placebo combined with 8 weeks of rehabilitation to improve motor and sensory function
Potential participants will be identified and approached 5 days to 8 weeks after stroke and randomized to 1 Supplementing traditional recruitment methods detailed participant information letter and consent form with women-centred aphasia-friendly recruitment video and leaflet ORDER or 2 Traditional participant information letter and consent form only TRAD For the ORDER arm the video and leaflet will be saved to a tablet and reviewed together with the Coordinator and potential participant The Coordinator will engage in discussion about the host trial prompting questions will be provided and will offer to leave the tablet with the person along with printed copies of the leaflet and participant information letter They will be encouraged to share these materials with their family members or friends who may assist with decision making For TRAD the Coordinator will review the information letter and consent form offer to leave these with the person to view again and encourage them to share these materials with their family members or friends who may assist with decision making For both arms the Coordinator will return in the following days to address any further questions and determine the decision whether to enroll in the trial
Objective 1 Feasibility will be determined as enrollment consentedapproached women consentedtotal consented and efficiency days to decision interactions between Site Coordinator and potential participants with a priori criteria for success for each indicator
For Objective 2 Barriers and facilitators individuals will be invited to complete a survey or participate in key-informant semi-structured interviews 15 enrolled 15 declined 10 Site Coordinators to share their perceptions of the enrollment and consent process reasons for declining to participate and recruitment reach and characteristics of individuals enrolled through ORDER and TRAD Purposive sampling will be used to obtain diversity across sex males females gender men women transgender non-binary and racial background and will train peer researchers with lived experience to conduct the interviews The interview guide will be co-developed with our patient partners and the research team Deductive content analysis of interview transcripts will be conducted and mapped to the Theoretical Domains Framework
For Objective 3 Preliminary estimates of effect enrollment and efficiency will be compared between ORDER and TRAD and Cohens d and f will be calculated for unadjusted and adjusted analyses to help inform future large-scaled trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None